Utility of HPLC as a tool in the transfer of analytical technology

American Pharmaceutical Review

Volumn 8, Issue 1, 2005, Pages 74-77

  Etse, Joseph ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; DRUG DOSAGE FORM; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RESEARCH; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

EID: 33749364302     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (8)

1. C.H. Dubin. Scale-up & technology transfer, from the laboratory to Commercial Production, Pharmaceutical Formulation & Quality, October/November, 19-21, (2003).
2. J. Etse in HPLC for Pharmaceutical Scientists, Ed. R. LoBrutto and Y. Kazakevich, John Wiley &Sons (To be published).
3. ICH-Q2A Guideline for Industry, Text on Validation of Analytical Procedures, March, (1995).
4. ICH-Q2B Guidance for Industry, Validation of Analytical Procedures: Methodology, November, (1996).
5. L.R. Snyder; JJ. Kirkland and J.L. Glajch, Practical HPLC Method Development, 2nd Edition, John Wiley & Sons, Inc (1997).
6. S. Scypinski, D. Roberts, M. Oates, and J. Etse, Pharmaceutical Research and Manufacturing Association Acceptable Analytical Practice for Analytical Method Transfer, Pharmaceutical Technology, March, 84-88 (2002).
7. E. McGonigle, Assay Validation and Inter-laboratory Transfer in Development and Validation of Analytical Methods, Ed. C.M. Riley and T.W. Rosanske, Elsevier Science Ltd, p. 3-13 (1996).
8. J.C. Miller and J.N. Miller in Statistics for Analytical Chemistry, Ellis Horwood, Chicester, p. 7 (1993).